Assistant Manager - OSD Production (Granulation) - Pithampur (Indore)

Rubicon Research; Pithampur; Sur place; INR 2 600 000 - 4 200 000; Plein temps

Résumé du poste

Rubicon Research in India is seeking a Senior Granulation Lead to manage the daily operations of the Granulation section in a regulated OSD manufacturing unit. You will ensure cGMP compliance, oversee a large shift workforce, and defend production practices during international audits.

You will plan and monitor wet/dry granulation, direct compression blending, and equipment validation, while driving continuous improvement through Lean Six Sigma tools and CAPAs, and coordinating with QA, QC,

Qualifications

• 10–15 years of core production experience exclusively within a regulatory-approved OSD manufacturing plant.
• Experience leading a large shop floor team (40+ personnel).
• Proven track record defending granulation processes during USFDA/MHRA/global audits.
• Strong knowledge of cGMP, QMS and CAPA processes.
• Willingness to work in rotational shifts and meet tight production schedules.

Responsabilités

• Lead and manage a production team of approximately 40 members in granulation.
• Plan, monitor, and execute daily granulation operations involving RMG, Fluid Bed Dryers, Blenders, Sifters, and Milling systems.
• Oversee wet granulation, dry granulation (roller compaction), and direct compression blending.
• Ensure Line Clearance protocols and machine sanitization before batch processing.
• Review and verify Batch Manufacturing Records (BMR), logbooks, and equipment cleaning records for real-time compliance.
• Front-face major international regulatory audits (USFDA, MHRA, EU-GMP, WHO) for all granulation workflows.
• Participate in Quality Management System (QMS) activities, investigating deviations and implementing CAPAs.
• Supervise qualification, validation, and calibration of granulation equipment with Engineering.
• Coordinate cross-functionally with QA, QC, Warehouse, and Maintenance to achieve targets.
• Draft, review, and update section SOPs to ensure audit readiness.
• Map training matrices and conduct systematic technical and safety training for the team.
• Implement Lean Six Sigma or continuous improvement tools to reduce batch cycle time and material waste.

Connaissances

Granulation mastery

Large-scale leadership

Audit front-facing

QMS & troubleshooting

Technical communication

Formation

B.Pharm / M.Pharm / M.Sc Chemistry

Description du poste

Role & responsibilities

Purpose

To lead, manage, and optimize daily operations within the Granulation section of a regulated Oral Solid Dosage (OSD) manufacturing unit. This role ensures full compliance with cGMP norms, manages a large workforce, and successfully defends production practices during international regulatory audits.

Responsibilities

• Lead and manage a large production team of approx. 40 members, including shift executives, supervisors, and operators.
• Plan, monitor, and execute daily granulation operations involving RMG, Fluid Bed Dryers (FBD), Blenders, Sifters, and Milling systems.
• Oversee critical manufacturing processes like wet granulation, dry granulation (roller compaction), and direct compression blending.
• Ensure strict Line Clearance protocols and machine sanitization procedures are strictly executed before batch processing.
• Review and verify Batch Manufacturing Records (BMR), logbooks, and equipment cleaning records online for real-time compliance.
• Front-face major international regulatory audits (USFDA, MHRA, EU-GMP, WHO) for all granulation section workflows.
• Participate actively in Quality Management System (QMS) activities, investigating floor deviations and implementing effective CAPAs.
• Supervise the qualification, validation, and calibration of granulation machinery in coordination with the Engineering team.
• Coordinate cross-functionally with QA, QC, Warehouse, and Maintenance teams to achieve weekly production targets.
• Draft, review, and update section-specific Standard Operating Procedures (SOPs) to ensure continuous audit readiness.
• Map training matrices and execute systematic technical and safety training programs for the entire 40-member team.
• Implement Lean Six Sigma or continuous improvement tools to reduce batch cycle time and minimize material waste on the floor.

Required Skills

• Granulation Technology Mastery: Deep operational knowledge of modern, automated granulation equipment (PLC/SCADA-driven RMG, FBD, Roller Compactors).
• Large-Scale Leadership: Proven ability to direct, motivate, and manage a massive shift workforce of 40+ technical personnel.
• Audit Front-Facing: Strong capability and confidence to face and defend production practices during strict USFDA and MHRA inspections.
• QMS & Troubleshooting: Proficient in executing root cause analysis for processing failures and handling deviations or shop-floor incidents.
• Technical Communication: Excellent documentation habits along with the verbal skills required for cross-functional alignment and audit justification.

Preferred Candidate Details

• Education: Full-time B.Pharm , M.Pharm, M.Sc Chemistry degree from a recognized university.
• Experience Range: 10 to 15 years of core production experience exclusively within a regulatory-approved OSD manufacturing plant.
• Leadership Stature: Must have past experience managing a large-scale shop floor team of at least 30 to 40 people simultaneously.
• Audit Track Record: Demonstrated history of successfully defending granulation blocks during recent USFDA / MHRA / global regulatory audits.
• Operational Flexibility: Total readiness to work in all rotational shifts and handle intense corporate target delivery schedules.